Important Risk Information

The Edwards SAPIEN 3 Transcatheter Heart Valve System and Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System are indicated for relief of aortic stenosis...

Edwards SAPIEN 3 THV System and Edwards SAPIEN 3 Ultra THV System

Indications:

The Edwards SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve system is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a Heart Team, including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy.

The Edwards SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve system is indicated for patients with symptomatic heart disease due to failing (stenosed, insufficient, or combined) of a surgical or transcatheter bioprosthetic aortic valve or surgical bioprosthetic mitral valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥ 8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical co-morbidities unmeasured by the STS risk calculator).

Contraindications (Who should not use):

The Edwards SAPIEN 3 Transcatheter Heart Valve System and Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System should not be used in patients who:

  • Cannot tolerate medications that thin the blood or prevent blood clots from forming.
  • Have an active infection in the heart or elsewhere.

Warnings:

  • There may be an increased risk of stroke in transcatheter aortic valve replacement procedures, compared to other standard treatments for aortic stenosis in the high or greater risk population.
  • If an incorrect valve size for your anatomy is used, it may lead to heart injury, valve leakage, movement, or dislodgement.
  • Patients should talk to their doctor if they have significant heart disease, a mitral valve device or are sensitive to cobalt, nickel, chromium, molybdenum, titanium, manganese, silicon, and/or polymeric materials.
  • The Edwards SAPIEN 3 Ultra and SAPIEN 3 valves may not last as long in younger patients, or patients with a disease that results in more calcium in their blood.
  • During the procedure, your doctors should monitor the dye used in the body; if used in excess it could lead to kidney damage. X-ray guidance used during the procedure may cause injury to the skin, which may be painful, damaging, and long-lasting.
  • Patient’s creatinine level should be measured prior to the procedure.
  • Patients who have already had a valve replaced should be carefully assessed by their physician prior to receiving a new valve to ensure proper placement of the new valve.
  • Injury can occur if the delivery system is not used properly.
  • Transcatheter heart valve patients should talk to their physicians about the potential need for medications that thin the blood or prevent blood clots from forming.

Precautions:

The long-term durability of the Edwards SAPIEN 3 Ultra and SAPIEN 3 transcatheter heart valves are not known at this time. Regular medical follow-up is recommended to evaluate how well a patient’s heart valve is performing. Limited clinical data are available for transcatheter aortic valve replacement in patients who are born with an aortic heart valve that has only two leaflets and who are determined to be at low risk for open heart surgery. Long-term durability of the valve has not been established.

The safety and effectiveness of the transcatheter heart valves are also not known for patients who have:

  • An aortic heart valve that is not calcified, contains only one leaflet, has leaflets with large pieces of calcium that may block the vessels that supply blood to the heart or in which the main problem is that the valve leaks.
  • Previous prosthetic ring in any position.
  • Previous atrial septal occlude.
  • A heart that does not pump well, has thickening of the heart muscle, with or without blockage, unusual ultrasound images of the heart that could represent irregularities such as a blood clot, a diseased mitral valve that is calcified or leaking, or Gorlin syndrome, a condition that affects many areas of the body and increases the risk of developing various cancers and tumors.
  • Low white, red or platelet blood cell counts, or history of bleeding because the blood does not clot properly.
  • Diseased, abnormal or irregularly shaped vessels leading to the heart. Vessels which are heavily diseased or too small for associated delivery devices, or a large amount of calcification at the point of entry.
  • Allergies to blood-thinning medications or dye injected during the procedure.
  • For a valve in valve procedure, there is a risk of leakage if the previously implanted tissue valve is not securely in place or if it is damaged. There is also the possibility that a partially detached valve leaflet from the previously implanted valve could block a blood vessel.
  • Additional pre-procedure imaging will be completed to evaluate proper sizing.

Potential risks associated with the procedure include:

  • Death, stroke, paralysis (loss of muscle function), permanent disability, or severe bleeding.
  • Risks to the heart, including heart attack or heart failure, a heart that does not pump well, irregular heartbeat that may result in a need for a permanent pacemaker, chest pain, heart murmur, false aneurysm, recurring aortic stenosis (narrowing), too much fluid around the heart, injury to the structure of the heart.
  • Risks to your lungs or breathing, including difficulty breathing, fainting, buildup of fluid in or around the lungs, weakness or inability to exercise.
  • Risks involving bleeding or your blood supply, including formation of a blood clot, high or low blood pressure, limited blood supply, a decrease in red blood cells, or abnormal lab values, bleeding in the abdominal cavity, collection of blood under the skin.
  • Additional risks, including life-threatening infection, dislodgement of calcified material, air embolism (air bubbles in the blood vessels), poor kidney function or failure, nerve injury, fever, allergic reaction to anesthesia or dye, reoperation, pain, infection or bleeding at incision sites, or swelling.

Additional potential risks specifically associated with the use of the heart valves include:

  • Valve movement after deployment, blockage or disruption of blood flow through the heart, need for additional heart surgery and possible removal of the Edwards SAPIEN 3 Ultra and SAPIEN 3 valves, a blood clot that requires treatment, damage to the valve (e.g., wear, breakage, recurring aortic stenosis), nonstructural valve dysfunction (e.g., leakage, inappropriate sizing or positioning, blockage, excess tissue in growth, blood cell damage, etc.) or mechanical failure of the delivery system and/or accessories.

CAUTION: Federal (United States) law restricts these devices to sale by or on the order of a physician.